CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 me…
ConMed Corporation · Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
Open FDA's page for this record- Cfres ID
- 221676
- Product res number
- Z-3018-2026
- Event date initiated
- 2026-07-14
- Event date posted
- 2026-08-26
- Recall status
- Open, Classified
- Res event number
- 99498
- Product code
- MAI
- Code info
- UDI:10845854042472, Lot number 1513167
- Firm FEI number
- 3001451571
- Recalling firm
- ConMed Corporation
- Address 1
- 525 French Rd
- City
- Utica
- State
- NY
- Postal code
- 13502-5945
- Additional info contact
- Brent Lalomia 269-377-2187
- Reason for recall
- Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
- Root cause description
- Labeling design
- Product quantity
- 2 units
- Distribution pattern
- US Nationwide distribution in the state of TX.
- Product description
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
- Action
On July 14, 2026, Conmed Corporation issued an Urgent Medical Device Correction to affected consignees via email: Conmed Corporation asked consignees to take the following actions: 1. Replace the Patient Implant Card with the corrected Patient Implant Card included with this notification. 2.Retain the corrected Patient Implant Card for your records and discard the incorrect PIC to ensure accurate device traceability and recordkeeping. 3. If you have provided these devices to other facilities or distributors, or you are a distributor, please forward this information as appropriate. 4. Review your inventory for any of the devices listed in Table 1. We ask that you contact all departments within your facility and any other facilities within your organization that may have received affected products. 5. Devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly. 6. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to genesyscrossft2026@conmed.com 7. For devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly. 8. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to genesyscrossft2026@conmed.com
- K numbers
- K101100
- Harmonized identifiers (openFDA)
- Device name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- K number
- K062466, K993061, K180768, K063497, K990361, K041305, K113534, K091041, K041698, K051219, K151342, K101679, K950275, K170639, K990999, K180763, K183501, K120078, K011985, K231787, K192032, K193558, K221099, K983577, K083268, K142948, K003970, K012334, K140855, K011299, K200725, K231326, K250528, K981340, K062782, K093844, K193157, K993453, K031519, K202806 +181 more
- Registration number
- 1221934, 3013176080, 3015718210, 1834331, 3014252644, 3010041511, 3019269298, 3014560508, 1226183, 3016851379, 3004365956, 3008110533, 1048735, 3003604053, 3013086329, 1319660, 1450662, 3012470322, 2936485, 3021393544, 3015539532, 1825034, 3015974593, 1221051, 3030655570, 1000517406, 9681465, 3015207155, 9610612, 3004638532, 3005941719, 2183946, 1219602, 3004549189, 3035366890, 3010273872, 3014302784, 1643264, 2024024, 2530154 +109 more
- FEI number
- 3002806315, 1221934, 3013176080, 3015718210, 3014252644, 1000116116, 3010041511, 3019269298, 3002757549, 3014560508, 3016851379, 3004365956, 3002807113, 3008110533, 1048735, 3001595430, 3003604053, 3013086329, 1450662, 2936485, 3012470322, 3002929183, 3021393544, 3015539532, 1000185904, 1825034, 3015974593, 1221051, 3030655570, 1000517406, 3003854593, 3015207155, 3002807231, 3004638532, 3035366890, 1219602, 3002821504, 3010273872, 3014302784, 1643264 +109 more